Announcement TypeThis Program announcement (PA) , in combination with
three other PARs (PAR-06-490,
PAR-06-491,
PAR-06-493),
represents a modification of a prior announcement, PAR-04-001,
which was previously released on October 1, 2004.

Update: The following update relating to this announcement has been issued:

January 24, 2007 - See Notice (NOT-GM-07-100) Notice of Institutes Participating in the Support of Competitive Research (SCORE) SC1 and SC2 Awards and Guidance on PI Eligibility to Apply for SCORE Individual Awards.

This PA provides updated guidelines for the National Institute of General
Medical Sciences (NIGMS) Minority Biomedical Research Support (MBRS) Support
of Competitive Research (SCORE) Program SC2 mechanism for Pilot Project
Awards.

The SCORE Program is a developmental program designed to increase the research
competitiveness of faculty at minority-serving institutions (MSIs), and
the research capabilities of MSIs. To better achieve these objectives, the
existing SCORE (S06) program, which had the structure of a non-thematic
program project, has been revised so that separate funding opportunities
exist for individual investigator-initiated research awards and for a stand-alone
institutional award. The mechanisms used for these funding opportunities
are the SC1, SC2 and SC3 awards for individual investigators and the S06
award for institutions. The funding opportunities of the SC1 (PAR-06-491),
SC3 (PAR-06-493)
and S06 (PAR-06-490)
award mechanisms may be found at the NIGMS website, http://www.nigms.nih.gov/Minority/MBRS/.
Research proposed under any of the investigator-initiated SCORE award mechanisms
must fall within the scope of the NIH mission, which is science in pursuit of fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to extend healthy
life and reduce the burdens of illness and disability.

This announcement for the SC2 award outlines the individual investigator-initiated
pilot research project for faculty members who are in their early stages
of development and are seeking to gather preliminary data or more advanced
investigators interested in switching to a different research field from
the one in which an individual has been engaged in and published.

Twenty-five to 30 SC2 awards totaling $2-2.2 million (direct costs) are expected
to be made each year.

The SC2 awards may not exceed $225,000 (direct costs) for the entire length
of the award which may be one to three years maximum. Yearly requests need
not be of the same amount but must be determined based on $25,000 module
increments.

Because the nature and scope of the proposed research will vary from application
to application, it is anticipated that the size and duration of each award
will also vary. The total amount awarded and the number of awards will depend
upon the number of applications submitted to each SCORE award mechanism
as well as the scientific quality, duration, and costs of the applications
received.

A maximum of 25 individual SCORE awards (i.e., SC1, SC2, and SC3 awards)
will be granted to any single MSI.

This announcement will become effective for applications submitted for the
September 18, 2006 deadline. As of this date, applications submitted in
response to PAR 04-001 (i.e., multi-research projects) will not be accepted.

Applications may be submitted by MSIs defined as domestic post-secondary
that have more than 50% student enrollment from groups underrepresented
in biomedical and behavioral research. Faculty from institutions that have
well developed environments for the conduct of research and/or research
training and external support from NIH R01 or equivalent awards are not
eligible to apply for SCORE.

Any individual with the skills, resources, and knowledge to conduct the proposed
research is invited to work with his/her institution to develop an application
for support. Typically, the PI of a SCORE investigator-initiated research
project possesses a Ph.D. or M.D./Ph.D. degree and must have a full-time
faculty appointment at the applicant institution. Emeritus/retired professors
or investigators who have or have had a significant track
record of non-MBRS external research fundingare considered to be fully developed and may not apply for this award.

An individual PI may only submit one application to any of the SCORE investigator-initiated
awards and may only hold one SCORE individual research award at a time .
Applicants may not be the PI of a funded S06 subproject grant or any other
NIH investigator-initiated research grant at the time of the award of a
SC2 grant. Pilot project awards are not renewable.

In the NIH Revitalization Act of 1993, NIH was encouraged
to increase the number of underrepresented minorities participating in biomedical
and behavioral research. In response to the Act, starting in 1996 the Minority
Biomedical Research Support (MBRS) Branch of the Minority Opportunities in
Research Division (MORE) of NIGMS offered institutional grants under the Support
of Competitive Research (SCORE) program. The objective of the SCORE program
is to foster the development of faculty at minority serving institutions (MSIs)
with more than 50% student enrollment of individuals from groups underrepresented
in biomedical and behavioral research in order to increase their research
competitiveness and promote their transition to non-SCORE external sources
of funding. Additionally, SCORE seeks to enhance the institutional research
capabilities to facilitate faculty research. These objectives are expected
to translate into an increase in the numbers of individuals from groups underrepresented
in biomedical and behavioral research professionally engaged in these areas
of research. SCORE grants are offered to eligible minority-serving institutions.

Historically, MSIs have significantly contributed to the
scientific training of students from underrepresented groups, i.e., African
Americans, Hispanic Americans, Native Americans, and natives of the U.S. Pacific
Islands. Faculty members at these institutions, who are involved in underrepresented
student training, often engage in competitive research projects. Such investigator-initiated
research contributes to basic knowledge in the biomedical and behavioral sciences,
allows faculty to stay at the cutting edge of their disciplines, and impacts
the quality of their teaching.

Because the individual focus of scholarly research at MSIs,
the SCORE program has been revamped to offer MSIs’ individual investigators
the possibility to apply for funding opportunities according to their developmental
level. Additionally, the SCORE program offers separate institutional funding
to strengthen the research environment that will foster faculty participation
in research. Due to this change, the SCORE program now offers three kinds
of individual investigator-initiated awards (SC1, SC2, and SC3, see below)
and an independent S06 institutional award which replace the “old” institutional
S06 mechanism in which there was an administrative core with a combination
of regular and/or pilot subprojects.

The revamped SCORE program offers support for individual
investigator-initiated research projects of different scope but limited to
the NIH mission, to allow faculty at MSIs to conduct high-quality research
and to increase their research competitiveness by progressively enhancing
the pace and productivity of their projects. It is an expectation of the SCORE
Program that the more productive SCORE PIs will transition to non-SCORE sources
of external support within a reasonable time period.

The SCORE mechanisms available to investigators according
to their experience/track record are:

Research Advancement Award (SC1) for those investigators
who seek to enhance their research productivity to be able to compete for
non-SCORE support.

Pilot Project Award (SC2) for those who are at the beginning stages of a
research career and who are interested in testing a new idea and/or generating
preliminary data or for more experienced investigators interested in switching
to a different field of research.

Research Continuance Award (SC3) for those investigators who have been
engaged in scholarly research and published and who seek to continue to conduct
competitive research of limited scope.

The SC2 mechanism lets investigators, normally in their
earlier stages of development, to test a new idea or gather preliminary data
to establish a new line of research, or it allows more experienced investigators
to switch to a different research area from the one in which an individual
has been engaged in and published. Mentorship from productive, established
scientists in the proposed field of research is required, especially for beginning
investigators. Additionally, any investigator applying for the SC2 mechanism
must demonstrate that accomplishing the objectives of the pilot project is
a first step in a long-term plan aimed at becoming established in a given
biomedical/behavioral area covered by the NIH mission and securing other external
funding. PIs who successfully complete a pilot project may apply for either
an SC1 or SC3 funding opportunity depending on their developmental goals.
Pilot project support may be requested for one to three years maximum and
is not renewable.

The principal difference between a SC2 pilot project and
an SC1 or SC3 award is that the pilot allows an individual to study and develop
a new idea for which he/she has no preliminary data. Any individual planning
to submit a pilot research project is advised to assess the field of study,
evaluate his/her credentials and expertise, determine the resources necessary
to conduct the project, and work on a clear hypothesis before initiating the
writing of a proposal. He/she is also encouraged to consult the instructions
of PHS form 398 (4/2006 revision), which provides general guidance on how
to prepare an NIH investigator-initiated application.

PIs who have previously received S06 subproject, SC1, or
SC3 awards may only apply for SC2 support if: 1) they intend to change research
fields and develop a different line of research from that in which they have
been engaged in and published, and 2) have no other active external research
support.

Twenty-five to 30 SC2 awards totaling $2-$2.2 million dollars (direct costs)
are expected to be made each year.

The anticipated amount of individual SC2 awards is expected to range between
$50,000 to $100,000 maximum direct costs per year. Yearly requests need
not be of the same amount but must be determined based on $25,000 module
increments.

SC2 awards may not exceed $225,000 (direct costs) for the entire length of
the award which may be one to three years maximum.

Because the nature and scope of
the proposed research will vary from application to application, it is anticipated
that the size and duration of each award will also vary. Although the financial
plans of the IC(s) provide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium
participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization
has any of the following characteristics:

A public or private post secondary educational institution,
such as a university or college awarding associate, undergraduate or graduate
degrees located in the United States of America or its territories including
Puerto Rico, Guam and Virgin Islands with more than 50 percent student enrollment
at the applicant institution from groups underrepresented in the biomedical
and behavioral sciences such as African American, Hispanic American, Native
American, Alaska Natives or natives of the U.S. Pacific Islands.

An Indian tribe that has a recognized governing body
and that performs substantial governmental functions, or an Alaska Regional
Corporation (ARC), as defined in the Alaska Native Claims Settlement Act
(43 U.S.C. 1601 et. Seq.).

If the applicant institution has a significantly high
student enrollment from groups underrepresented in the biomedical or behavioral
sciences but less than 50%, the institution may be eligible if the Secretary
of the Department of Health and Human Services, through the MBRS Chief,
determines that the institution has demonstrated special commitment to the
retention and graduation of students from groups underrepresented in the
biomedical and behavioral sciences and to the hiring and retention of science
faculty from underrepresented groups. Additionally, institutions should
demonstrate a clear and compelling institutional need for SCORE developmental
support. Institutions with well-developed environments for the conduct of
research and/or research training and significant support from NIH R01 or
equivalent awards are generally not suitable applicants for the SCORE program.
For information regarding eligibility please contact MBRS Chief (see Section VII. Agency Contacts).

Foreign Institutions are not eligible to apply.

Eligible MSIs need not have an S06 award for its faculty
to apply for SCORE individual awards.

1.B. Eligible Individuals

Any individual with the skills,
knowledge, and resources necessary to carry out the proposed research is invited
to work with their institution to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.Typically
the PI of a SCORE application possesses a Ph.D. or M.D./Ph.D. degree. He/she
must also have a full-time faculty appointment at the applicant institution
and be eligible to apply for a NIH R01 research grant. Postdoctoral fellows,
research fellows, and part-time or adjunct faculty are not eligible to apply
for SCORE individual awards. An applicant may not be the Principal Investigator
of any other NIH investigator-initiated research grant or a PI of an S06 subproject
at the time an SC2 award is made.

The maximum number of individual SCORE applications/awards
(either SC1, SC2 or SC3) that a combination of individual investigators from
a single MSI may hold is 25. Research at foreign sites and/or foreign collaborations/components
are not allowed.

A PI may only apply for/receive
one individual SCORE award at a time. Additionally, pilot research projects
(SC2 awards) are not renewable and must fall within the scope of the NIH mission.
Emeritus/retired professors or investigators who have or have had a significant
track record of non-MBRS external research funding are considered fully developed
and may not apply for any of the SCORE investigator-initiated research awards.
Because of the developmental nature of the SC2 award mechanism, no Co-PIs
are allowed.

Institutions receiving a new or
renewal S06 award during January-September, 2006 may submit individual SC1,
SC2 or SC3 (not S06) applications to a combined maximum of 25 total S06 subprojects
and SCORE SC1, SC2, or SC3 individual investigator awards. However, in this
case, individual investigator-initiated SC1, SC2 or SC3 applications may only
be submitted by PIs who are not already receiving S06 support (see 1.B. Eligible
Individuals).

Institutions that have an S06 grant
in place prior to January, 2006 are not eligible to apply for any of the new
SCORE individual or institutional awards until the submission of a renewal
application.

Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The D&B number should
be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.

SCORE investigator-initiated research projects are limited to the NIH mission.
SCORE PIs are strongly encouraged to visit the NIH website, http://www.nih.gov, to search the NIH archives for
all past and currently funded NIH grants and research areas.

In the preparation of SC2 pilot research projects, follow the PHS 398 instructions.

If animal and/or human subjects are to be used in the research carefully
follow PHS 398 instructions regarding the questions that need to be answered
and the submission of the required Targeted/Planned Enrollment Tables and
Inclusion Enrollment Report Tables (for additional information refer to

Modular Budget Format Page. Follow
instructions in PHS 398 (4/2006 revision). Refer to the Budget Instructions
of the research grant application at http://grants2.nih.gov/grants/funding/phs398/phs398.html
for step-by step-instructions for preparing modular budgets. Note that applicants
request direct costs in $25,000 modules and that the total direct costs for
the entire length of the award (not to exceed three years) is $225,000. The
maximum direct costs amount that may be requested for each year is $100,000.

In the “Biographical Sketch” of
the PI, list the education and training, selected publications with full citations,
position(s), any honors, and any grant support, with information, including
overall goals and responsibilities, on research projects ongoing or completed
during the last three years. Also provide for the PI only information on his
(her) previous or current experience supervising students from underrepresented
groups in research, and/or other relationships within the institutional framework
(e.g., cross-departmental research collaborations).

Under the Research Plan’s “Specific
Aims” section include not only the pilot project’s research objectives but
the PI’s developmental objectives as related to the long-term development
of a new line of research.

The Research Plan for a pilot project
should be prepared following PHS 398 instructions (4/2006 revision) except
for the page limit that should not exceed 12 pages for items A-D, including
figures, charts, tables, and diagrams. In the “Background and Significance”
section of the Research Plan include a subheading entitled Institutional Data.
In this part, which is limited to two pages (counted as part of the 12-page
limit), include the following:

The total student enrollment at
the institution and the number and percent of underrepresented minorities
(e.g. Native American, African American, Hispanic American, natives of the
U.S. Pacific Islands) in the total student population;

Number and percent of underrepresented minority
students (undergraduate and graduate) enrolled in the sciences relevant to
biomedical and behavioral research;

Number and percent of total and underrepresented minority faculty
in the sciences relevant to biomedical and behavioral research and the total
number of faculty and of underrepresented minority faculty from these departments
participating in funded research.

PIs proposing to switch research
areas must include in the “Background and Significance” section another subheading
entitled “Rationale for the Development of a New Research Area”. In this part,
the PI must briefly summarize any accomplishments resulting for previous SCORE
funding and explain the reasons that have led him/her to seek support for
a different line of research.

In the “Research Design and Methods”
include a subheading on the Role of the Mentor as it relates to the project
and the PI’s development. Letters of collaboration/support should be placed
after the literature cited (see PHS 398 instructions).

A revised application may be submitted.
The revised application must include an Introduction that addresses fully
the questions/issues raised by the reviewers of the previous application.
In addition, the body of the application must indicate, by changes in font
or other means, the revised sections (see PHS 398 instructions).

3.A.1. Letter of Intent A letter of intent is not required for the funding
opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant
application forms found in the PHS 398 instructions for preparing a research
grant application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

Applications must be received on or before the application receipt/submission date(s) described
above (Section IV.3.A.). If an application is received after that date, it
will be returned to the applicant without review .

Upon receipt applications will be evaluated for completeness
by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response
to this funding opportunity that is essentially the same as one currently
pending initial merit review unless the applicant withdraws the pending application.
The NIH will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of a substantial revision
of an application already reviewed, but such application must include an Introduction
addressing the previous critique.

Pre-Award Costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project,
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

SCORE SC2 awards include some restrictions as to how
the funds may be used. The following account summarizes allowable and non-allowable
costs under the SCORE SC2 mechanism.

Allowable Costs

Costs essential to the conduct
of the research projects, such as technical assistance, equipment, travel,
and supplies are allowed.

Faculty salaries, typically based on full-time,
nine-month contract, are reimbursed according to person months dedicated to
the proposed research. However, SCORE academic year or summer support for
faculty can not be used to increase one’s actual institutional salary, supplement
it, or establish the institutional base salary.

Summer-salary support based on person months spent
on the SCORE research project is allowed if permitted by institutional policy.
The maximum summer-salary support provided by the program may not exceed the
equivalent of two months or another length of time specified by the institution
as its policy or whichever is shorter.

Travel costs for mentor, external consultants/collaborators
or PI’s travel to collaborator’s or mentor’s institution are allowed.

Consortium arrangements are only allowed with SCORE-eligible
institutions.

Unallowable Costs

Costs for student development
(e.g. student stipend, salary or tuition), textbooks, journals, memberships,
and Internet or cell phone subscription costs are not allowed.

Employees of the applicant institution may not serve
as paid consultants.

Support for foreign institutions or foreign components/consortia/collaborators/consultants
in research projects are not allowed.

Travel for technical personnel
is not allowed.

Funds for faculty salaries cannot be used to supplement
the PI’s or collaborators’ actual academic year salary or to increase the
base by which academic year PI or collaborators’ salaries are calculated.

Collaborators/consultants at a SCORE-ineligible
institution are expected to have their own research funds, i.e., SCORE grant
funds may not be utilized to provide collaborators/consultants support for
the conduct of research projects such as salary for technical personnel or
to purchase equipment or supplies.

Salary compensation for mentors

Secretarial/clerical support

6. Other Submission Requirements

Not applicable.

Section V.
Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process.

2. Review and Selection Process

Applications that are complete will be evaluated for
scientific and technical merit by an appropriate review group convened by
NIGMS in accordance
with the review criteria stated below.

As part of the initial merit review, all applications
will:

Undergo a selection process in which only those applications
deemed to have the highest scientific merit, generally the top half of applications
under review, will be discussed and assigned a priority score.

Receive a written critique

Receive a second level of review by the NIGMS National Advisory Council.

The following will be considered
in making funding decisions:

Scientific merit of the proposed project as determined
by peer review

Availability of funds

Relevance of program priorities

Potential contribution to achieving the MBRS goal of
increasing the number of individuals from underrepresented groups who participate
in biomedical and behavioral research

The goals of NIH supported research
are to advance our understanding of biological systems, to improve the control
of disease, and to enhance health. In their written critiques, reviewers will
be asked to comment on each of the following criteria in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge or clinical practice
be advanced? What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?Is the proposed research appropriate for a pilot project
and will the information sought lead to testable hypotheses? If the PI accomplishes
the project objectives what is the likelihood that he/she will be able to
build on the anticipated findings to pursue a long-term research project?

Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? Are
the PI’s developmental objectives reasonable and what is the likelihood that
they will be accomplished?

Innovation: Is the project original and innovative? For example: Does the
project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or technologies
for this area?

Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Does the investigative
team bring complementary and integrated expertise to the project (if applicable)?Do the investigator’s credentials and experience render
confidence that he/she is well poised to succeed in establishing the research
line proposed and securing subsequent funding? Do the mentor’s credentials
and role on the project provide convincing evidence that the mentoring relationship
will foster the applicant’s development?

Environment: Does
the scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features
of the scientific environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?

Overall Evaluation:
Summarize the major factors from the five review criteria above that contribute
or detract from scientific merit. In addition, evaluate whether the proposed
project addresses the developmental objectives of SCORE, especially of the
SC2 award mechanism, which are to increase the competitiveness of investigators
at early stages of their research career or allow more senior investigators
to switch to another research area so that they can compete for other external
funding for a more ambitious project based on the preliminary data obtained.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:

Resubmitted application: Response
to previous critiques.

Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals
of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.

Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of
the porposed modular budget related to the requested period of support and
the proposed pilot research.

Length of Support: The reasonableness
of the proposed period of support in relation to the proposed research. The
priority score should not be affected by the evaluation of the length of support.

Program staff will be responsible
for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making recommendations
about funding applications. Program staff may negotiate modifications of the
data and resource sharing plans with the awardee before recommending funding
of an application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of the resource sharing will be evaluated as part of the administrative
review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award
Dates

Earliest possible dates when awards will be made will be January for applications
reviewed at the September Council meeting, April for applications reviewed
at the January Council meeting and July for applications reviewed at the May
Council meeting.

Section VI.
Award Administration Information

1. Award Notices

After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA Commons.

If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant.
For details, applicants may refer to the NIH Grants Policy Statement Part
II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official
(designated in item 12 on the Application Face Page). If a grantee is not
email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

The annual progress (refer to PHS
2590) must detail the progress accomplished towards each specific aim and
provide a list of peer-reviewed publications resulting from SCORE support.
Information on the level of funding (dollars per year) during the previous
grant period and on the number of technical personnel (technicians, postdoctoral
research associates, and other research associates) who participated in the
project (whether or not paid with SCORE funds) must be included in the progress
report.

Section VII. Agency Contacts

We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators
proposing clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require
for all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must report
annual accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)to
be used in the proposed research. Applications that do not provide this information
will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.

NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly
accessible on-line journal articles. Unless otherwise specified in this
solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution reviewers
that their anonymity may be compromised when they directly access an Internet
site.

Healthy People 2010:The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC
241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and
92. All awards are subject to the terms and conditions, cost principles, and
other considerations described in the NIH Grants Policy Statement. The
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov/.